FDA.reportPublic FDA data

Application 213592

Type
ANDA
Sponsor
CENTAUR PHARMS PVT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL6.25MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-981Zolpidem TartrateZolpidem TartrateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-981Zolpidem TartrateZolpidem TartrateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-982Zolpidem TartrateZolpidem TartrateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-982Zolpidem TartrateZolpidem TartrateBreckenridge Pharmaceutical, Inc.ANDACurrent
55700-971Zolpidem TartrateZolpidem TartrateQuality Care Products, LLCANDACurrent
64330-623Zolpidem TartrateZolpidem TartrateCentaur Pharmaceuticals Private LimitedANDACurrent
64330-624Zolpidem TartrateZolpidem TartrateCentaur Pharmaceuticals Private LimitedANDACurrent
68788-8118Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-8118Zolpidem TartrateZolpidem TartratePreferred Pharmaceuticals Inc.ANDACurrent
76420-494Zolpidem TartrateZolpidem TartrateAsclemed USA, Inc.ANDACurrent
76420-496Zolpidem TartrateZolpidem TartrateAsclemed USA, Inc.ANDACurrent